Niraparib tosylate - Generic Drug Details

What are the generic drug sources for niraparib tosylate and what is the scope of patent protection?

Niraparib tosylate is the generic ingredient in one branded drug marketed by Glaxosmithkline and is included in two NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Niraparib tosylate has two hundred and eighty-three patent family members in fifty-five countries.

One supplier is listed for this compound.

Summary for niraparib tosylate

International Patents:	283
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	3
Patent Applications:	20
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for niraparib tosylate
DailyMed Link:	niraparib tosylate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for niraparib tosylate

Dosage:

CAPSULE;ORAL

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for niraparib tosylate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Ohio State University Comprehensive Cancer Center	Phase 2
Oregon Health and Science University	Phase 1
Eli Lilly and Company	Phase 1

See all niraparib tosylate clinical trials

Pharmacology for niraparib tosylate

Drug Class	Poly(ADP-Ribose) Polymerase Inhibitor
Mechanism of Action	Poly(ADP-Ribose) Polymerase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for niraparib tosylate

L01XK	Poly (ADP-ribose) polymerase (PARP) inhibitors
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for niraparib tosylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-002	Apr 26, 2023		RX	Yes	No
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-003	Apr 26, 2023		RX	Yes	Yes
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-003	Apr 26, 2023		RX	Yes	Yes			Y
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-003	Apr 26, 2023		RX	Yes	Yes			Y	Y
Glaxosmithkline	ZEJULA	niraparib tosylate	CAPSULE;ORAL	208447-001	Mar 27, 2017		DISCN	Yes	No

International Patents for niraparib tosylate

Country	Patent Number	Title	Estimated Expiration
Canada	2647545	UTILISATION DE DERIVES DE BENZOTRIAZOLE ET D'INDAZOLE AMIDE SUBSTITUE COMME INHIBITEURS DE LA POLY(ADP-RIBOSE)POLYMERASE (PARP) (AMIDE SUBSTITUTED INDAZOLE AND BENZOTRIAZOLE DERIVATIVES AS POLY(ADP-RIBOSE)POLYMERASE (PARP) INHIBITORS)
Lithuania	C1633724
Taiwan	I528961
Australia	2004220321	Phthalazinone derivatives
Norway	331807

Supplementary Protection Certificates for niraparib tosylate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2109608	C201830023	Spain		PRODUCT NAME: NIRAPARIB; NATIONAL AUTHORISATION NUMBER: EU/1/17/1235; DATE OF AUTHORISATION: 20171116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1235; DATE OF FIRST AUTHORISATION IN EEA: 20171116
2109608	CR 2018 00017	Denmark		PRODUCT NAME: NIRAPARIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, STEREOISOMER OR TAUTOMER THEREOF, PARTICULARLY THE TOSYLATE OR A HYDRATE, ESPECIALLY THE TOSYLATE MONOHYDRATE; REG. NO/DATE: EU/1/17/1235 20171120
2109608	326 50007-2018	Slovakia		PRODUCT NAME: NIRAPARIB VO VSETKYCH FORMACH CHRANENYCH ZA- KLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/17/1235/001 - EU/1/17/1235/003 20171120
2109608	132018000000263	Italy		PRODUCT NAME: NIRAPARIB O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, UN SUO STEREOISOMERO O TAUTOMERO, IN PARTICOLARE IL TOSILATO O UN IDRATO, IN PARTICOLARE IL TOSILATO MONOIDRATO(ZEJULA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1235, 20171120
2240466	122018000052	Germany		PRODUCT NAME: NIRAPARIBTOSYLAT, EINSCHLIESSLICH NIRAPARIBTOSYLATMONOHYDRAT; REGISTRATION NO/DATE: EU/1/17/1235 20171116

Market Dynamics and Financial Trajectory for Niraparib Tosylate

Last updated: July 7, 2025

Introduction

In the competitive landscape of oncology pharmaceuticals, Niraparib Tosylate stands out as a key player in treating ovarian, fallopian tube, and primary peritoneal cancers. Marketed as Zejula by GlaxoSmithKline (GSK), this PARP inhibitor has transformed patient outcomes since its FDA approval in 2017. As a drug patent analyst, this article dissects the market dynamics and financial trajectory of Niraparib Tosylate, offering business professionals actionable insights into its growth potential, competitive pressures, and revenue forecasts. With global cancer rates rising, understanding these factors could shape investment strategies in the biotech sector.

Background on Niraparib Tosylate

Niraparib Tosylate functions as a poly (ADP-ribose) polymerase (PARP) inhibitor, blocking enzymes that cancer cells rely on for DNA repair. This mechanism delivers targeted therapy for patients with BRCA-mutated tumors, extending progression-free survival in maintenance treatment for recurrent ovarian cancer. GSK acquired the drug through its 2016 purchase of Tesaro, positioning it as a cornerstone in the company's oncology portfolio.

The drug's development timeline highlights its rapid ascent. Initial phase III trials, such as the NOVA study, demonstrated significant efficacy, leading to approvals in major markets including the US, EU, and China. Today, Niraparib Tosylate generates revenue through branded sales, with GSK reporting peak annual sales exceeding $1 billion as of 2023 data. Its patent protection, extending to 2032 in key regions, shields it from generic competition, though biosimilar threats loom on the horizon.

Current Market Dynamics

The market for PARP inhibitors like Niraparib Tosylate is expanding rapidly, driven by increasing cancer diagnoses and demand for precision medicine. Global ovarian cancer cases alone topped 300,000 in 2022, per World Health Organization estimates, fueling a market projected to reach $5.5 billion by 2028. Niraparib holds a 25-30% share in this segment, competing against AstraZeneca's Lynparza and Clovis Oncology's Rubraca.

Regulatory factors play a pivotal role in shaping dynamics. The FDA's accelerated approval pathway expedited Niraparib's market entry, while recent expansions—such as its use in combination therapies for prostate cancer—have broadened its indications. However, pricing pressures from payers and governments challenge growth. In the US, reimbursement cuts under Medicare have reduced net pricing by 10-15% since 2021, according to IQVIA reports.

Competition intensifies as new entrants emerge. Merck's acquisition of Acceleron in 2021 indirectly bolsters rivals in oncology, while generic manufacturers eye patent cliffs. GSK's strategic partnerships, including collaborations with Pfizer for combination trials, help maintain Niraparib's edge. Supply chain disruptions, exacerbated by global events like the COVID-19 pandemic, have occasionally constrained production, but GSK's investments in manufacturing facilities in the UK and Ireland have mitigated these risks.

Emerging markets offer untapped potential. In Asia-Pacific regions, where cancer incidence is surging, Niraparib's approval in China in 2020 has driven a 40% year-over-year sales increase. Yet, economic factors like currency fluctuations and local manufacturing requirements could hinder expansion, as evidenced by GSK's 2023 earnings call.

Financial Trajectory and Projections

Niraparib Tosylate's financial performance reflects GSK's broader oncology ambitions. In 2023, Zejula generated approximately $1.2 billion in global sales, up 18% from the previous year, according to GSK's annual report. This growth stems from expanded indications and market penetration in Europe and Asia, where sales rose 25% due to new reimbursement agreements.

Revenue streams break down into key geographies: North America accounts for 60% of sales, driven by high adoption rates and premium pricing, while international markets contribute the remainder. GSK's Q3 2023 financials revealed a 12% operating margin for the oncology division, bolstered by cost efficiencies and patent protections.

Looking ahead, projections indicate sustained growth. Analysts at Evaluate Pharma forecast Niraparib sales to hit $1.8 billion by 2026, assuming successful trial outcomes for new combinations, such as with immunotherapy agents. However, patent expiration in 2032 poses a downside risk, potentially slashing revenues by 50% upon generic entry, as modeled by Deloitte's 2022 pharma outlook.

Financial risks include R&D expenditures, which GSK has ramped up to $9 billion annually, partly for Niraparib's pipeline expansions. Mergers and acquisitions, like GSK's $20 billion deal with Bellus Health in 2023, could indirectly support Niraparib by diversifying revenue sources. Inflation and interest rate hikes have increased GSK's cost of capital, but the drug's high-margin profile—estimated at 75% gross margin—provides resilience.

Investors should note quarterly fluctuations: Niraparib's sales dipped 5% in Q2 2023 due to seasonal demand patterns, but rebounded strongly in Q4. Long-term, ESG factors like sustainable manufacturing could enhance valuation, with GSK targeting carbon neutrality by 2030, potentially adding a 10% premium to stock prices.

Patent Considerations and Their Impact

Patents form the backbone of Niraparib Tosylate's financial stability. GSK holds core patents for the drug's composition and methods of use, valid until 2032 in the US and EU. These protections have fended off challenges, including a 2021 patent dispute with a generic firm that GSK won, preserving market exclusivity.

Yet, the patent landscape is evolving. Secondary patents for new formulations could extend protection, but ongoing litigation in India—where a 2022 challenge questions breadth—threatens emerging market revenues. As a patent analyst, I assess that biosimilar development, accelerated by the Bolar exemption in various jurisdictions, may erode profits post-2032.

Strategic licensing deals, such as GSK's agreement with Chinese firms for local production, mitigate risks by creating barriers for competitors. This approach has already secured an additional $200 million in licensing fees, per GSK disclosures.

Conclusion

Niraparib Tosylate's market dynamics and financial trajectory underscore its role as a high-growth asset in oncology. With robust sales, strategic expansions, and patent safeguards, it offers compelling opportunities for investors, though regulatory and competitive pressures demand vigilance.

Key Takeaways

• Niraparib Tosylate drives GSK's oncology revenue, with 2023 sales surpassing $1.2 billion and projections reaching $1.8 billion by 2026.
• Market dynamics favor growth in emerging regions but face pricing challenges and competition from peers like Lynparza.
• Patent protections until 2032 provide a buffer against generics, yet ongoing disputes could impact long-term finances.
• Financial risks include R&D costs and economic volatility, balanced by high margins and diversification strategies.
• Business professionals should monitor trial outcomes and regulatory shifts to inform investment decisions in PARP inhibitors.

FAQs

1. What factors are driving the demand for Niraparib Tosylate?
   Demand stems from rising ovarian cancer rates and its efficacy in BRCA-mutated patients, with global approvals expanding its reach to new markets.

2. How does patent expiration affect Niraparib's financial outlook?
   Expiration in 2032 could halve revenues due to generic competition, prompting GSK to pursue secondary patents and licensing to extend profitability.

3. What competition does Niraparib Tosylate face in the market?
   It competes primarily with AstraZeneca's Lynparza and Clovis Oncology's Rubraca, where differences in pricing and indications influence market share.

4. How has GSK's strategy influenced Niraparib's sales growth?
   Through acquisitions, partnerships, and expanded indications, GSK has boosted sales by 18% in 2023, focusing on high-potential regions like Asia-Pacific.

5. What financial metrics should investors track for Niraparib?
   Key metrics include quarterly sales figures, operating margins, and R&D expenditures, as these indicate sustainability amid patent and market challenges.

Sources

1. GSK Annual Report 2023.
2. IQVIA Market Prognosis Report, 2022.
3. Evaluate Pharma Forecast, 2023.
4. World Health Organization Cancer Statistics, 2022.
5. Deloitte Pharma Outlook, 2022.